Computer Assisted Knee Arthroplasty Instrumentation, Systems, and Processes

ABSTRACT

Instrumentation, systems, and processes for tracking anatomy, instrumentation, trial implants, implants, and references, and rendering images and data related to them in connection with surgical operations, for example total knee arthroplasties (“TKA”). These instrumentation, systems, and processes are accomplished by using a computer to intraoperatively obtain images of body parts and to register, navigate, and track surgical instruments. Disclosed in this document are also alignment modules and other structures and processes which allow for coarse and fine alignment of instrumentation and other devices relative to bone for use in connection with the tracking systems of the present invention.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/229,372 filed on Aug. 27, 2002, which is continuation-in-part of U.S.patent application Ser. No. 10/084,012 filed on Feb. 27, 2002, whichclaims the benefit of U.S. Provisional Application No. 60/355,899 filedon Feb. 11, 2002 and Provisional Application No. 60/271,818 filed onFeb. 27, 2001. The disclosure of each prior application is incorporatedby reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The field of the invention includes instrumentation, systems, andprocesses for tracking anatomy, implements, instrumentation, trialimplants, implant components and virtual constructs or references, andrendering images and data related to them in connection with orthopedic,surgical and other operations, for example Total Knee Arthroplasty(“TKA”). Anatomical structures and such items may be attached to orotherwise associated with fiducial functionality, and constructs may beregistered in position using fiducial functionality whose position andorientation can be sensed and tracked by systems and processes in threedimensions in order to perform TKA. Such structures, items andconstructs can be rendered onscreen properly positioned and orientedrelative to each other using associated image files, data files, imageinput, other sensory input, based on the tracking. Such instrumentation,systems, and processes, among other things, allow surgeons to navigateand perform TKA using images that reveal interior portions of the bodycombined with computer generated or transmitted images that showsurgical implements, instruments, trials, implants, and/or other deviceslocated and oriented properly relative to the body part. Suchinstrumentation, systems, and processes allow, among other things, moreaccurate and effective resection of bone, placement and assessment oftrial implants and joint performance, and placement and assessment ofperformance of actual implants and joint performance.

BACKGROUND AND SUMMARY

A leading cause of wear and revision in prosthetics such as kneeimplants, hip implants and shoulder implants is less than optimumimplant alignment. In a Total Knee Arthroplasty, for example, currentinstrument design for resection of bone limits the alignment of thefemoral and tibial resections to average values for varus/valgusflexion/extension, and external/internal rotation. Additionally,surgeons often use visual landmarks or “rules of thumb” for alignmentwhich can be misleading due to anatomical variability. Intramedullaryreferencing instruments also violate the femoral and tibial canal. Thisintrusion increases the risk of fat embolism and unnecessary blood lossin the patient. Surgeons also rely on instrumentation to predict theappropriate implant size for the femur and tibia instead of the abilityto intraoperatively template the appropriate size of the implants foroptimal performance. Another challenge for surgeons is soft tissue orligament balancing after the bone resections have been made. Releasingsome of the soft tissue points can change the balance of the knee;however, the multiple options can be confusing for many surgeons. Inrevision TKA, for example, many of the visual landmarks are no longerpresent, making alignment and restoration of the joint line difficult.The present invention is applicable not only for knee repair,reconstruction or replacement surgery, but also repair, reconstructionor replacement surgery in connection with any other joint of the body aswell as any other surgical or other operation where it is useful totrack position and orientation of body parts, non-body components and/orvirtual references such as rotational axes, and to display and outputdata regarding positioning and orientation of them relative to eachother for use in navigation and performance of the operation.

Several providers have developed and marketed various forms of imagingsystems for use in surgery. Many are based on CT scans and/or MRI dataor on digitized points on the anatomy. Other systems align preoperativeCT scans, MRIs or other images with intraoperative patient positions. Apreoperative planning system allows the surgeon to select referencepoints and to determine the final implant position. Intraoperatively,the system calibrates the patient position to that preoperative plan,such as using a “point cloud” technique, and can use a robot to makefemoral and tibial preparations.

Instrumentation, systems, and processes according to one embodiment ofthe present invention use position and/or orientation tracking sensorssuch as infrared sensors acting stereoscopically or otherwise to trackpositions of body parts, surgery-related items such as implements,instrumentation, trial prosthetics, prosthetic components, and virtualconstructs or references such as rotational axes which have beencalculated and stored based on designation of bone landmarks. Processingcapability such as any desired form of computer functionality, whetherstandalone, networked, or otherwise, takes into account the position andorientation information as to various items in the position sensingfield (which may correspond generally or specifically to all or portionsor more than all of the surgical field) based on sensed position andorientation of their associated fiducials or based on stored positionand/or orientation information. The processing functionality correlatesthis position and orientation information for each object with storedinformation regarding the items, such as a computerized fluoroscopicimaged file of a femur or tibia, a wire frame data file for rendering arepresentation of an instrumentation component, trial prosthesis oractual prosthesis, or a computer generated file relating to a rotationalaxis or other virtual construct or reference. The processingfunctionality then displays position and orientation of these objects ona screen or monitor, or otherwise. Thus, instrumentation, systems, andprocesses according to one embodiment of the invention can display andotherwise output useful data relating to predicted or actual positionand orientation of body parts, surgically related items, implants, andvirtual constructs for use in navigation, assessment, and otherwiseperforming surgery or other operations.

As one example, images such as fluoroscopy images showing internalaspects of the femur and tibia can be displayed on the monitor incombination with actual or predicted shape, position and orientation ofsurgical implements, instrumentation components, trial implants, actualprosthetic components, and rotational axes in order to allow the surgeonto properly position and assess performance of various aspects of thejoint being repaired, reconstructed or replaced. The surgeon maynavigate tools, instrumentation, trial prostheses, actual prostheses andother items relative to bones and other body parts in order to performTKA's more accurately, efficiently, and with better alignment andstability. Instrumentation, systems, and processes according to thepresent invention can also use the position tracking information and, ifdesired, data relating to shape and configuration of surgical relateditems and virtual constructs or references in order to produce numericaldata which may be used with or without graphic imaging to perform taskssuch as assessing performance of trial prosthetics statically andthroughout a range of motion, appropriately modifying tissue such asligaments to improve such performance and similarly assessingperformance of actual prosthetic components which have been placed inthe patient for alignment and stability. Instrumentation, systems, andprocesses according to the present invention can also generate databased on position tracking and, if desired, other information to providecues on screen, aurally or as otherwise desired to assist in the surgerysuch as suggesting certain bone modification steps or measures which maybe taken to release certain ligaments or portions of them based onperformance of components as sensed by instrumentation, systems, andprocesses according to the present invention.

According to a preferred embodiment of instrumentation, systems, andprocesses according to the present invention, at least the followingsteps are involved:

1. Obtain appropriate images such as fluoroscopy images of appropriatebody parts such as femur and tibia, the imager being tracked in positionvia an associated fiducial whose position and orientation is tracked byposition/orientation sensors such as stereoscopic infrared (active orpassive) sensors according to the present invention.

2. Register tools, instrumentation, trial components, prostheticcomponents, and other items to be used in surgery, each of whichcorresponds to a fiducial whose position and orientation can be trackedby the position/orientation sensors.

3. Locating and registering body structure such as designating points onthe femur and tibia using a probe associated with a fiducial in order toprovide the processing functionality information relating to the bodypart such as rotational axes.

4. Navigating and positioning instrumentation such as cuttinginstrumentation in order to modify bone, at least partially using imagesgenerated by the processing functionality corresponding to what is beingtracked and/or has been tracked, and/or is predicted by the system, andthereby resecting bone effectively, efficiently and accurately.

5. Navigating and positioning trial components such as femoralcomponents and tibial components, some or all of which may be installedusing impactors with a fiducial and, if desired, at the appropriate timediscontinuing tracking the position and orientation of the trialcomponent using the impactor fiducial and starting to track thatposition and orientation using the body part fiducial on which thecomponent is installed.

6. Assessing alignment and stability of the trial components and joint,both statically and dynamically as desired, using images of the bodyparts in combination with images of the trial components whileconducting appropriate rotation, anterior-posterior drawer andflexion/extension tests and automatically storing and calculatingresults to present data or information which allows the surgeon toassess alignment and stability.

7. Releasing tissue such as ligaments if necessary and adjusting trialcomponents as desired for acceptable alignment and stability.

8. Installing implant components whose positions may be tracked at firstvia fiducials associated with impactors for the components and thentracked via fiducials on the body parts in which the components areinstalled.

9. Assessing alignment and stability of the implant components and jointby use of some or all tests mentioned above and/or other tests asdesired, releasing tissue if desired, adjusting if desired, andotherwise verifying acceptable alignment, stability and performance ofthe prosthesis, both statically and dynamically.

This process, or processes including it or some of it may be used in anytotal or partial joint repair, reconstruction or replacement, includingknees, hips, shoulders, elbows, ankles and any other desired joint inthe body.

Such processes are disclosed in U.S. Ser. No. 60/271,818 filed Feb. 27,2001, entitled Image Guided System for Arthroplasty, which isincorporated herein by reference as are all documents incorporated byreference therein.

Instrumentation, systems, and processes according to the presentinvention represent significant improvement over other previousinstrumentation, systems, and processes. For instance, systems which useCT and MRI data generally require the placement of reference framespreoperatively which can lead to infection at the pin site. Theresulting 3D images must then be registered, or calibrated, to thepatient anatomy intraoperatively. Current registration methods are lessaccurate than the fluoroscopic system. These imaging modalities are alsomore expensive. Some “imageless” systems, or non-imaging systems,require digitizing a large number of points to define the complexanatomical geometries of the knee at each desired site. This can be verytime intensive resulting in longer operating room time. Other imagelesssystems determine the mechanical axis of the knee by performing anintraoperative kinematic motion to determine the center of rotation atthe hip, knee, and ankle. This requires placement of reference frames atthe iliac crest of the pelvis and in or on the ankle. This calculationis also time consuming at the system must find multiple points indifferent planes in order to find the center of rotation. This is alsoproblematic in patients with a pathologic condition. Ligaments and softtissues in the arthritic patient are not normal and thus will give acenter of rotation that is not desirable for normal knees. Roboticsystems require expensive CT or MRI scans and also require pre-operativeplacement of reference frames, usually the day before surgery. Thesesystems are also much slower, almost doubling operating room time andexpense.

Some systems provide variable alignment modules, but none of thesesystems allow gross placement of cutting instruments followed by fineadjustment of cutting instruments through computer assisted navigationtechnology. Further, these systems can only be used with tibialinstrumentation and cannot be used for femoral alignment and cutting.

None of these systems can effectively track femoral and/or tibial trialsduring a range of motion and calculate the relative positions of thearticular surfaces, among other things. Also, none of them currentlymake suggestions on ligament balancing, display ligament balancingtechniques, or surgical techniques. Additionally, none of these systemscurrently track the patella.

An aspect of the present invention is to use computer processingfunctionality in combination with imaging and position and/ororientation tracking sensors to present to the surgeon during surgicaloperations visual and data information useful to navigate, track and/orposition implements, instrumentation, trial components, prostheticcomponents and other items and virtual constructs relative to the humanbody in order to improve performance of a repaired, replaced orreconstructed knee joint.

Another aspect of the present invention is to use computer processingfunctionality in combination with imaging and position and/ororientation tracking sensors to present to the surgeon during surgicaloperations visual and data information useful to assess performance of aknee and certain items positioned therein, including components such astrial components and prosthetic components, for stability, alignment andother factors, and to adjust tissue and body and non-body structure inorder to improve such performance of a repaired, reconstructed orreplaced knee joint.

Another aspect of the present invention is to use computer processingfunctionality in combination with imaging and position and/ororientation tracking sensors to present to the surgeon during surgicaloperations visual and data information useful to show predicted positionand movement of implements, instrumentation, trial components,prosthetic components and other items and virtual constructs relative tothe human body in order to select appropriate components, resect boneaccurately, effectively and efficiently, and thereby improve performanceof a repaired, replaced or reconstructed knee joint. Further areas ofapplicability of the present invention will become apparent from thedetailed description provided hereinafter. It should be understood thatthe detailed description and specific examples, while indicating thepreferred embodiment of the invention, are intended for purposes ofillustration only and are not intended to limit the scope of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present inventionand together with the written description serve to explain theprinciples, characteristics, and features of the invention. In thedrawings:

FIG. 1 is a schematic view of a particular embodiment ofinstrumentation, systems, and processes according to the presentinvention.

FIG. 2 is a view of a knee prepared for surgery, including a femur and atibia, to which fiducials according to one embodiment of the presentinvention have been attached.

FIG. 3 is a view of a portion of a leg prepared for surgery according tothe present invention with a C-arm for obtaining fluoroscopic imagesassociated with a fiducial according to one embodiment of the presentinvention.

FIG. 4 is a fluoroscopic image of free space rendered on a monitoraccording to one embodiment of the present invention.

FIG. 5 is a fluoroscopic image of femoral head obtained and renderedaccording one embodiment of the present invention.

FIG. 6 is a fluoroscopic image of a knee obtained and rendered accordingto one embodiment of the present invention.

FIG. 7 is a fluoroscopic image of a tibia distal end obtained andrendered according to one embodiment of the present invention.

FIG. 8 is a fluoroscopic image of a lateral view of a knee obtained andrendered according to one embodiment of the present invention.

FIG. 9 is a fluoroscopic image of a lateral view of a knee obtained andrendered according to one embodiment of the present invention.

FIG. 10 is a fluoroscopic image of a lateral view of a tibia distal endobtained and rendered according to one embodiment of the presentinvention.

FIG. 11 shows a probe according to one embodiment of the presentinvention being used to register a surgically related component fortracking according to one embodiment of the present invention.

FIG. 12 shows a probe according to one embodiment of the presentinvention being used to register a cutting block for tracking accordingto one embodiment of the present invention.

FIG. 13 shows a probe according to one embodiment of the presentinvention being used to register a tibial cutting block for trackingaccording to one embodiment of the present invention.

FIG. 14 shows a probe according to one embodiment of the presentinvention being used to register an alignment guide for trackingaccording to one embodiment of the present invention.

FIG. 15 shows a probe according to one embodiment of the presentinvention being used to designate landmarks on bone structure fortracking according one embodiment of the present invention.

FIG. 16 is another view of a probe according to one embodiment of thepresent invention being used to designate landmarks on bone structurefor tracking according one embodiment of the present invention.

FIG. 17 is another view of a probe according to one embodiment of thepresent invention being used to designate landmarks on bone structurefor tracking according one embodiment of the present invention.

FIG. 18 is a screen face produced according to one embodiment of thepresent invention during designation of landmarks to determine a femoralmechanical axis.

FIG. 19 is a view produced according to one embodiment of the presentinvention during designation of landmarks to determine a tibialmechanical axis.

FIG. 20 is a screen face produced according to one embodiment of thepresent invention during designation of landmarks to determine anepicondylar axis.

FIG. 21 is a screen face produced according to one embodiment of thepresent invention during designation of landmarks to determine ananterior-posterior axis.

FIG. 22 is a screen face produced according to one embodiment of thepresent invention during designation of landmarks to determine aposterior condylar axis.

FIG. 23 is a screen face according to one embodiment of the presentinvention which presents graphic indicia which may be employed to helpdetermine reference locations within bone structure.

FIG. 24 is a screen face according to one embodiment of the presentinvention showing mechanical and other axes which have been establishedaccording to one embodiment of the present invention.

FIG. 25 is another screen face according to one embodiment of thepresent invention showing mechanical and other axes which have beenestablished according to one embodiment of the present invention.

FIG. 26 is another screen face according to one embodiment of thepresent invention showing mechanical and other axes which have beenestablished according to one embodiment of the present invention.

FIG. 27 shows navigation and placement of an extramedullary rodaccording to one embodiment of the present invention.

FIG. 28 is a view of an extramedullary rod according to one embodimentof the present invention.

FIG. 29 is another view showing navigation and placement of anextramedullary rod according to one embodiment of the present invention.

FIG. 30 is a screen face produced according to one embodiment of thepresent invention which assists in navigation and/or placement of anextramedullary rod.

FIG. 31 is another view of a screen face produced according to oneembodiment of the present invention which assists in navigation and/orplacement of an extramedullary rod.

FIG. 32 is a view which shows navigation and placement of an alignmentguide according to one embodiment of the present invention.

FIG. 33 is another view which shows navigation and placement of analignment guide according to one embodiment of the present invention.

FIG. 34 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 35 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 36 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 37 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIGS. 38A-C are views showing certain aspects of a gimbal alignmentmodule according to one embodiment of the present invention.

FIGS. 39A-C are views showing other aspects of the module shown in FIGS.38A-C.

FIGS. 40A-C show other aspects of the module shown in FIGS. 38A-C.

FIG. 41 shows additional aspects of the module shown in FIGS. 38A-C.

FIGS. 42A and B are an exploded perspective view showing certain aspectsof a tibial gimbal alignment module according to one embodiment of thepresent invention.

FIG. 43 shows other aspects of the module shown in FIGS. 42A and 42B.

FIG. 44 shows additional aspects of the module shown in FIGS. 42A and42B.

FIG. 45 additional aspects of the module shown in FIGS. 42A and 42B.

FIGS. 46A and 46B show another structure for alignment modules accordingto alternative embodiments of the present invention.

FIG. 47 shows another structure for alignment modules according toalternative embodiments of the present invention.

FIG. 48 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 49 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 50 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 51 is a screen face which shows a fluoroscopic image of bone incombination with computer generated images of axes and components inaccordance with one embodiment of the present invention.

FIG. 52 is a view showing placement of a cutting block according to oneembodiment of the present invention.

FIG. 53 is a screen face according to one embodiment of the presentinvention which may be used to assist in navigation and placement ofinstrumentation.

FIG. 54 is another screen face according to one embodiment of thepresent invention which may be used to assist in navigation and/orplacement of instrumentation.

FIG. 55 is a view showing placement of an alignment guide according toone embodiment of the present invention.

FIG. 56 is another view showing placement of a cutting block accordingto one embodiment of the present invention.

FIG. 57 is a view showing navigation and placement of the cutting blockof FIG. 45.

FIG. 58 is another view showing navigation and placement of a cuttingblock according to one embodiment of the present invention.

FIG. 59 is a view showing navigation and placement of a tibial cuttingblock according to one embodiment of the present invention.

FIG. 60 is a screen face according to one embodiment of the presentinvention which may be used to assist in navigation and placement ofinstrumentation.

FIG. 61 is another screen face according to one embodiment of thepresent invention which may be used to assist in navigation andplacement of instrumentation.

FIG. 62 is another screen face according to one embodiment of thepresent invention which may be used to assist in navigation andplacement of instrumentation.

FIG. 63 is another screen face according to one embodiment of thepresent invention which may be used to assist in navigation andplacement of instrumentation.

FIG. 64 is another screen face according to one embodiment of thepresent invention which may be used to assist in navigation andplacement of instrumentation.

FIG. 65 is a view showing navigation and placement of a femoralcomponent using an impactor to which a fiducial according to oneembodiment of the present invention is attached.

FIG. 66 is a view showing navigation and placement of a tibial trialcomponent according to one embodiment of the present invention.

FIG. 67 is a view showing articulation of trial components during trialreduction according to one embodiment of the present invention.

FIG. 68 is a screen face according to one embodiment of the presentinvention which may be used to assist in assessing joint function.

FIG. 69 is a screen face according to one embodiment of the presentinvention which may be used to assist in assessing joint function.

FIG. 70 is a screen face according to one embodiment of the presentinvention which may be used to assist in assessing joint function.

FIG. 71 is a screen face according to one embodiment of the presentinvention which contains images and textural suggestions for assistingin assessing performance and making adjustments to improve performanceof a joint in accordance with one aspect of the invention.

FIG. 72 is a screen face according to one embodiment of the presentinvention which contains images and textural suggestions for assistingin assessing performance and making adjustments to improve performanceof a joint in accordance with one aspect of the invention.

FIG. 73 is a screen face according to one embodiment of the presentinvention which contains images and textural suggestions for assistingin assessing performance and making adjustments to improve performanceof a joint in accordance with one aspect of the invention.

FIG. 74 is a screen face according to one embodiment of the presentinvention which contains images and textural suggestions for assistingin assessing performance and making adjustments to improve performanceof a joint in accordance with one aspect of the invention.

FIG. 75 is a computer generated graphic according to one embodiment ofthe present invention which allows visualization of trial or actualcomponents installed in the bone structure according to one embodimentof the invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

Instrumentation, systems, and processes according to a preferredembodiment of the present invention use computer capacity, includingstandalone and/or networked, to store data regarding spatial aspects ofsurgically related items and virtual constructs or references includingbody parts, implements, instrumentation, trial components, prostheticcomponents and rotational axes of body parts. Any or all of these may bephysically or virtually connected to or incorporate any desired form ofmark, structure, component, or other fiducial or reference device ortechnique which allows position and/or orientation of the item to whichit is attached to be sensed and tracked, preferably in three dimensionsof translation and three degrees of rotation as well as in time ifdesired. In the preferred embodiment, such “fidicuals” are referenceframes each containing at least three, preferably four, sometimes more,reflective elements such as spheres reflective of lightwave or infraredenergy, or active elements such as LEDs.

In a preferred embodiment, orientation of the elements on a particularfiducial varies from one fiducial to the next so that sensors accordingto the present invention may distinguish between various components towhich the fiducials are attached in order to correlate for display andother purposes data files or images of the components. In a preferredembodiment of the present invention, some fiducials use reflectiveelements and some use active elements, both of which may be tracked bypreferably two, sometimes more infrared sensors whose output may beprocessed in concert to geometrically calculate position and orientationof the item to which the fiducial is attached.

Position/orientation tracking sensors and fiducials need not be confinedto the infrared spectrum. Any electromagnetic, electrostatic, light,sound, radiofrequency or other desired technique may be used.Alternatively, each item such as a surgical implement, instrumentationcomponent, trial component, implant component or other device maycontain its own “active” fiducial such as a microchip with appropriatefield sensing or position/orientation sensing functionality andcommunications link such as spread spectrum RF link, in order to reportposition and orientation of the item. Such active fiducials, or hybridactive/passive fiducials such as transponders can be implanted in thebody parts or in any of the surgically related devices mentioned above,or conveniently located at their surface or otherwise as desired.Fiducials may also take the form of conventional structures such as ascrew driven into a bone, or any other three dimensional item attachedto another item, position and orientation of such three dimensional itemable to be tracked in order to track position and orientation of bodyparts and surgically related items. Hybrid fiducials may be partlypassive, partly active such as inductive components or transponderswhich respond with a certain signal or data set when queried by sensorsaccording to the present invention.

Instrumentation, systems, and processes according to a preferredembodiment of the present invention employ a computer to calculate andstore reference axes of body components such as in a TKA, for example,the mechanical axis of the femur and tibia. From these axes such systemstrack the position of the instrumentation and osteotomy guides so thatbone resections will locate the implant position optimally, usuallyaligned with the mechanical axis. Furthermore, during trial reduction ofthe knee, the systems provide feedback on the balancing of the ligamentsin a range of motion and under varus/valgus, anterior/posterior androtary stresses and can suggest or at least provide more accurateinformation than in the past about which ligaments the surgeon shouldrelease in order to obtain correct balancing, alignment and stability.Instrumentation, systems and processes according to the presentinvention allow the attachment of a variable alignment module so that asurgeon can grossly place a cutting block based on visual landmarks ornavigation and then finely adjust the cutting block based on navigationand feedback from the system.

Instrumentation, systems, and processes according to the presentinvention can also suggest modifications to implant size, positioning,and other techniques to achieve optimal kinematics. Instrumentation,systems, and processes according to the present invention can alsoinclude databases of information regarding tasks such as ligamentbalancing, in order to provide suggestions to the surgeon based onperformance of test results as automatically calculated by suchinstrumentation, systems, and processes.

FIG. 1 is a schematic view showing one embodiment of a system accordingto the present invention and one version of a setting according to thepresent invention in which surgery on a knee, in this case a Total KneeArthroplasty, may be performed. Instrumentation, systems, and processesaccording to the present invention can track various body parts such astibia 10 and femur 12 to which fiducials of the sort described above orany other sort may be implanted, attached, or otherwise associatedphysically, virtually, or otherwise. In the embodiment shown in FIG. 1,fiducials 14 are structural frames some of which contain reflectiveelements, some of which contain LED active elements, some of which cancontain both, for tracking using stereoscopic infrared sensors suitable,at least operating in concert, for sensing, storing, processing and/oroutputting data relating to (“tracking”) position and orientation offiducials 14 and thus components such as 10 and 12 to which they areattached or otherwise associated. Position sensor 16, as mentionedabove, may be any sort of sensor functionality for sensing position andorientation of fiducials 14 and therefore items with which they areassociated, according to whatever desired electrical, magnetic,electromagnetic, sound, physical, radio frequency, or other active orpassive technique. In the preferred embodiment, position sensor 16 is apair of infrared sensors disposed on the order of a meter, sometimesmore, sometimes less, apart and whose output can be processed in concertto provide position and orientation information regarding fiducials 14.

In the embodiment shown in FIG. 1, computing functionality 18 caninclude processing functionality, memory functionality, input/outputfunctionality whether on a standalone or distributed basis, via anydesired standard, architecture, interface and/or network topology. Inthis embodiment, computing functionality 18 is connected to a monitor onwhich graphics and data may be presented to the surgeon during surgery.The screen preferably has a tactile interface so that the surgeon maypoint and click on screen for tactile screen input in addition to orinstead of, if desired, keyboard and mouse conventional interfaces.Additionally, a foot pedal 20 or other convenient interface may becoupled to functionality 18 as can any other wireless or wirelineinterface to allow the surgeon, nurse or other desired user to controlor direct functionality 18 in order to, among other things, captureposition/orientation information when certain components are oriented oraligned properly. Items 22 such as trial components and instrumentationcomponents may be tracked in position and orientation relative to bodyparts 10 and 12 using fiducials 14.

Computing functionality 18 can process, store and output on monitor 24and otherwise various forms of data which correspond in whole or part tobody parts 10 and 12 and other components for item 22. For example, inthe embodiment shown in FIG. 1, body parts 10 and 12 are shown incross-section or at least various internal aspects of them such as bonecanals and surface structure are shown using fluoroscopic images. Theseimages are obtained using a C-arm attached to a fiducial 14. The bodyparts, for example, tibia 10 and femur 12, also have fiducials attached.When the fluoroscopy images are obtained using the C-arm with fiducial14, a position/orientation sensor 16 “sees” and tracks the position ofthe fluoroscopy head as well as the positions and orientations of thetibia 10 and femur 12. The computer stores the fluoroscopic images withthis position/orientation information, thus correlating position andorientation of the fluoroscopic image relative to the relevant body partor parts. Thus, when the tibia 10 and corresponding fiducial 14 move,the computer automatically and correspondingly senses the new positionof tibia 10 in space and can correspondingly move implements,instruments, references, trials and/or implants on the monitor 24relative to the image of tibia 10. Similarly, the image of the body partcan be moved, both the body part and such items may be moved, or the onscreen image otherwise presented to suit the preferences of the surgeonor others and carry out the imaging that is desired. Similarly, when anitem 22 such as an extramedullary rod 36 (See, e.g., FIG. 28),intramedullary rod, or other type of rod, that is being tracked moves,its image moves on monitor 24 so that the monitor shows the item 22 inproper position and orientation on monitor 24 relative to the femur 12.The rod 36 can thus appear on the monitor 24 in proper or improperalignment with respect to the mechanical axis and other features of thefemur 12, as if the surgeon were able to see into the body in order tonavigate and position rod 36 properly

The computer functionality 18 can also store data relating toconfiguration, size and other properties of items 22 such as implements,instrumentation, trial components, implant components and other itemsused in surgery. When those are introduced into the field ofposition/orientation sensor 16, computer functionality 18 can generateand display overlain or in combination with the fluoroscopic images ofthe body parts 10 and 12, computer generated images of implements,instrumentation components, trial components, implant components andother items 22 for navigation, positioning, assessment and other uses.

Additionally, computer functionality 18 can track any point in theposition/orientation sensor 16 field such as by using a designator or aprobe 26. The probe also can contain or be attached to a fiducial 14.The surgeon, nurse, or other user touches the tip of probe 26 to a pointsuch as a landmark on bone structure and actuates the foot pedal 20 orotherwise instructs the computer 18 to note the landmark position. Theposition/orientation sensor 16 “sees” the position and orientation offiducial 14 “knows” where the tip of probe 26 is relative to thatfiducial 14 and thus calculates and stores, and can display on monitor24 whenever desired and in whatever form or fashion or color, the pointor other position designated by probe 26 when the foot pedal 20 is hitor other command is given. Thus, probe 26 can be used to designatelandmarks on bone structure in order to allow the computer 18 to storeand track, relative to movement of the bone fiducial 14, virtual orlogical information such as mechanical axis 28, medial laterial axis 30and anterior/posterior axis 32 of femur 12, tibia 10 and other bodyparts in addition to any other virtual or actual construct or reference.

Instrumentation, systems, and processes according to an embodiment ofthe present invention such as the subject of FIGS. 2-75, can use theso-called FluoroNAV system and software provided by Medtronic SofamorDanek Technologies. Such systems or aspects of them are disclosed inU.S. Pat. Nos. 5,383,454; 5,871,445; 6,146,390; 6,165,81; 6,235,038 and6,236,875, and related (under 35 U.S.C. Section 119 and/or 120) patents,which are all incorporated herein by this reference. Any other desiredsystems can be used as mentioned above for imaging, storage of data,tracking of body parts and items and for other purposes. The FluoroNavsystem requires the use of reference frame type fiducials 14 which havefour and in some cases five elements tracked by infrared sensors forposition/orientation of the fiducials and thus of the body part,implement, instrumentation, trial component, implant component, or otherdevice or structure being tracked. Such systems also use at least oneprobe 26 which the surgeon can use to select, designate, register, orotherwise make known to the system a point or points on the anatomy orother locations by placing the probe as appropriate and signaling orcommanding the computer to note the location of, for instance, the tipof the probe. The FluoroNav system also tracks position and orientationof a C-arm used to obtain fluoroscopic images of body parts to whichfiducials have been attached for capturing and storage of fluoroscopicimages keyed to position/orientation information as tracked by thesensors 16. Thus, the monitor 24 can render fluoroscopic images of bonesin combination with computer generated images of virtual constructs andreferences together with implements, instrumentation components, trialcomponents, implant components and other items used in connection withsurgery for navigation, resection of bone, assessment and otherpurposes.

FIGS. 2-75 are various views associated with Total Knee Arthroplastysurgery processes according to one particular embodiment and version ofthe present invention being carried out with the FluoroNav systemreferred to above. FIG. 2 shows a human knee in the surgical field, aswell as the corresponding femur and tibia, to which fiducials 14 havebeen rigidly attached in accordance with this embodiment of theinvention. Attachment of fiducials 14 preferably is accomplished usingstructure that withstands vibration of surgical saws and otherphenomenon which occur during surgery without allowing any substantialmovement of fiducial 14 relative to body part being tracked by thesystem. FIG. 3 shows fluoroscopy images being obtained of the body partswith fiducials 14 attached. The fiducial 14 on the fluoroscopy head inthis embodiment is a cylindrically shaped cage which contains LEDs or“active” emitters for tracking by the sensors 16. Fiducials 14 attachedto tibia 10 and femur 12 can also be seen. The fiducial 14 attached tothe femur 12 uses LEDs instead of reflective spheres and is thus active,fed power by the wire seen extending into the bottom of the image.

FIGS. 4-10 are fluoroscopic images shown on monitor 24 obtained withposition and/or orientation information received by, noted and storedwithin computer 18. FIG. 4 is an open field with no body part image, butwhich shows the optical indicia which may be used to normalize the imageobtained using a spherical fluoroscopy wave front with the substantiallyflat surface of the monitor 24. FIG. 5 shows an image of the femur 12head. This image is taken in order to allow the surgeon to designate thecenter of rotation of the femoral head for purposes of establishing themechanical axis and other relevant constructs relating to of the femuraccording to which the prosthetic components will ultimately bepositioned. Such center of rotation can be established by articulatingthe femur within the acetabulum or a prosthesis to capture a number ofsamples of position and orientation information and thus in turn toallow the computer to calculate the average center of rotation. Thecenter of rotation can be established by using the probe and designatinga number of points on the femoral head and thus allowing the computer tocalculate the geometrical center or a center which corresponds to thegeometry of points collected. Additionally, graphical representationssuch as controllably sized circles displayed on the monitor can befitted by the surgeon to the shape of the femoral head on planar imagesusing tactile input on screen to designate the centers according to thatgraphic, such as are represented by the computer as intersection of axesof the circles. Other techniques for determining, calculating orestablishing points or constructs in space, whether or not correspondingto bone structure, can be used in accordance with the present invention.

FIG. 5 shows a fluoroscopic image of the femoral head while FIG. 6 showsan anterior/posterior view of the knee which can be used to designatelandmarks and establish axes or constructs such as the mechanical axisor other rotational axes. FIG. 7 shows the distal end of the tibia andFIG. 8 shows a lateral view of the knee. FIG. 9 shows another lateralview of the knee while FIG. 10 shows a lateral view of the distal end ofthe tibia.

Registration of Surgically Related Items

FIGS. 11-14 show designation or registration of items 22 which will beused in surgery. Registration simply means, however it is accomplished,ensuring that the computer knows which body part, item or constructcorresponds to which fiducial or fiducials, and how the position andorientation of the body part, item or construct is related to theposition and orientation of its corresponding fiducial or a fiducialattached to an impactor or other other component which is in turnattached to an item. Such registration or designation can be done beforeor after registering bone or body parts as discussed with respect toFIGS. 4-10. FIG. 11 shows a technician designating with probe 26 an item22 such as an instrument component to which fiducial 14 is attached. Thesensor 16 “sees” the position and orientation of the fiducial 14attached to the item 22 and also the position and orientation of thefiducial 14 attached to the probe 26 whose tip is touching a landmark onthe item 22. The technician designates onscreen or otherwise theidentification of the item and then activates the foot pedal orotherwise instructs the computer to correlate the data corresponding tosuch identification, such as data needed to represent a particularcutting block component for a particular knee implant product, with theparticularly shaped fiducial 14 attached to the component 22. Thecomputer has then stored identification, position and orientationinformation relating to the fiducial for component 22 correlated withthe data such as configuration and shape data for the item 22 so thatupon registration, when sensor 16 tracks the item 22 fiducial 14 in theinfrared field, monitor 24 can show the cutting block component 22moving and turning, and properly positioned and oriented relative to thebody part which is also being tracked. FIGS. 12-14 show similarregistration for other instrumentation components 22.

Registration of Anatomy and Constructs

Similarly, the mechanical axis and other axes or constructs of bodyparts 10 and 12 can also be “registered” for tracking by the system.Again, the system has employed a fluoroscope to obtain images of thefemoral head, knee and ankle of the sort shown in FIGS. 4-10. The systemcorrelates such images with the position and orientation of the C-armand the patient anatomy in real time as discussed above with the use offiducials 14 placed on the body parts before image acquisition and whichremain in position during the surgical procedure. Using these imagesand/or the probe, the surgeon can select and register in the computer 18the center of the femoral head and ankle in orthogonal views, usuallyanterior/posterior and lateral, on a touch screen. The surgeon uses theprobe to select any desired anatomical landmarks or references at theoperative site of the knee or on the skin or surgical draping over theskin, as on the ankle. These points are registered in three dimensionalspace by the system and are tracked relative to the fiducials on thepatient anatomy which are preferably placed intraoperatively. FIG. 15shows the surgeon using probe 26 to designate or register landmarks onthe condylar portion of femur 12 using probe 26 in order to feed to thecomputer 18 the position of one point needed to determine, store, anddisplay the epicondylar axis. (See FIG. 20 which shows the epicondylaraxis and the anterior-posterior plane and for lateral plane.) Althoughregistering points using actual bone structure such as in FIG. 15 is onepreferred way to establish the axis, a cloud of points approach by whichthe probe 26 is used to designate multiple points on the surface of thebone structure can be employed, as can moving the body part and trackingmovement to establish a center of rotation as discussed above. Once thecenter of rotation for the femoral head and the condylar component havebeen registered, the computer is able to calculate, store, and render,and otherwise use data for, the mechanical axis of the femur 12. FIG. 17once again shows the probe 26 being used to designate points on thecondylar component of the femur 12.

FIG. 18 shows the onscreen images being obtained when the surgeonregisters certain points on the bone surface using the probe 26 in orderto establish the femoral mechanical axis. The tibial mechanical axis isthen established by designating points to determine the centers of theproximal and distal ends of the tibia so that the mechanical axis can becalculated, stored, and subsequently used by the computer 18. FIG. 20shows designated points for determining the epicondylar axis, both inthe anterior/posterior and lateral planes while FIG. 21 shows suchdetermination of the anterior-posterior axis as rendered onscreen. Theposterior condylar axis is also determined by designating points or asotherwise desired, as rendered on the computer generated geometricimages overlain or displayed in combination with the fluoroscopicimages, all of which are keyed to fiducials 14 being tracked by sensors16.

FIG. 23 shows an adjustable circle graphic which can be generated andpresented in combination with orthogonal fluoroscopic images of thefemoral head, and tracked by the computer 18 when the surgeon moves iton screen in order to establish the centers of the femoral head in boththe anterior-posterior and lateral planes.

FIG. 24 is an onscreen image showing the anterior-posterior axis,epicondylar axis and posterior condylar axis from points which have beendesignated as described above. These constructs are generated by thecomputer 18 and presented on monitor 24 in combination with thefluoroscopic images of the femur 12, correctly positioned and orientedrelative thereto as tracked by the system. In the fluoroscopic/computergenerated image combination shown at left bottom of FIG. 24, a“sawbones” knee as shown in certain drawings above which contains radioopaque materials is represented fluoroscopically and tracked usingsensor 16 while the computer generates and displays the mechanical axisof the femur 12 which runs generally horizontally. The epicondylar axisruns generally vertically, and the anterior/posterior axis runsgenerally diagonally. The image at bottom right shows similarinformation in a lateral view. Here, the anterior-posterior axis runsgenerally horizontally while the epicondylar axis runs generallydiagonally, and the mechanical axis generally vertically.

FIG. 24, as is the case with a number of screen presentations generatedand presented by the system of FIGS. 4-75, also shows at center a listof landmarks to be registered in order to generate relevant axes andconstructs useful in navigation, positioning and assessment duringsurgery. Textual cues may also be presented which suggest to the surgeonnext steps in the process of registering landmarks and establishingrelevant axes. Such instructions may be generated as the computer 18tracks, from one step to the next, registration of items 22 and bonelocations as well as other measures being taken by the surgeon duringthe surgical operation.

FIG. 25 shows mechanical, lateral, anterior-posterior axes for the tibiaaccording to points are registered by the surgeon.

FIG. 26 is another onscreen image showing the axes for the femur 12.

Modifying Bone

After the mechanical axis and other rotation axes and constructsrelating to the femur and tibia are established, instrumentation can beproperly oriented to resect or modify bone in order to fit trialcomponents and implant components properly according to the embodimentof the invention shown in FIGS. 4-75. Instrumentation such as, forinstance, cutting blocks 34, to which fiducials 14 are mounted, can beemployed. The system can then track cutting block 34 as the surgeonmanipulates it for optimum positioning. In other words, the surgeon can“navigate” the cutting block 34 for optimum positioning using thesystem, the monitor, visual landmarks, and other devices, such asvariable alignment modules 54. In this manner, instrumentation may bepositioned according to the system of this embodiment in order to alignthe ostetomies to the mechanical and rotational axes or reference axeson an extramedullary rod 36 or any other structure that allows theinstrumentation to be positioned without invading the medullary canal.The touchscreen 24 can then also display the instrument, such as thecutting block 34 and/or the implant and/or the variable alignment module54 relative to the instruments and the rod 36 during this process, inorder, among other things, properly to select size of implant andperhaps implant type. As the instrument moves, the varus/valgus,flexion/extension and internal/external rotation of the relativecomponent position can be calculated and shown with respect to thereferenced axes; in the preferred embodiment, this can be done at a rateof six cycles per second or faster. The instrument position is thenfixed in the computer and physically and the bone resections are made.

FIG. 27 shows orientation of an extramedullary rod 36 to which afiducial 14 is attached via impactor 22. The surgeon views the screen 24which has an image as shown in FIG. 32 of the rod 36 overlain on or incombination with the femur 12 fluoroscopic image as the two are actuallypositioned and oriented relative to one another in space. The surgeonthen navigates the rod 36 into place preferably along the mechanicalaxis of the femur and drives it home with appropriate mallet or otherdevice.

FIG. 28 shows an extramedullary rod 36, according to one embodiment ofthe invention, which includes a first end that is adapted to fasten tobone and a second end that is adapted for attachment or connection to acutting block 34 or other instrumentation. In a preferred embodiment ofthis invention, the first end of the extramedullary rod 36 has apointed, splined tip 38 that is capable being being driven or otherwiseintroduced into and fastened to bone with a mallet, wrench or othersuitable tool or device. The tip can feature threads, curved spines, orany structure that is suitable for efficient and effective introductioninto and purchase of or fastening bone sufficient to support cuttingblock 34 or other instrumentation while being used to alter bone.Devices according to aspects of the present invention thus avoid theneed to bore a hole in the metaphysis of the femur and place a reamer orother rod 36 into the medullary canal which can cause fat embolism,hemorrhaging, infection and other untoward and undesired effects.

As shown in FIG. 28, the second end of the extramedullary rod 36 may beattached to a base member 40 (permanently or in releasable fashion) andthat is capable of permanent or releasable attachment to a cylindricalconnector 42. The cylindrical connector 42 is capable of permanent orreleasable attachment to a cylindrical knob 44 that has an integrated,circumferential groove 46. The circumferential groove 46 is adapted tosecure an impactor or any other desired structure to the second end ofthe extramedullary rod 36. The base member 40, connector 42, and knob 44may form a unitary structure that is capable of permanent or releasableattachment to an extramedullary rod 36. Any desired connection structurecan be employed.

FIG. 29 also shows the extramedullary rod 36 being located throughcomputer assisted navigation. FIG. 30 shows fluoroscopic images, bothanterior-posterior and lateral, with axes, and with a computer generatedand tracked image of the rod 36 superposed or in combination with thefluoroscopic images of the femur and tibia. FIG. 31 shows the rod 36superposed on the femoral fluoroscopic image similar to what is shown inFIG. 30.

FIG. 30 also shows other information relevant to the surgeon such as thename of the component being overlain on the femur image (new EM nail),suggestions or instructions at the lower left, and angle of the rod 36in varus/valgus and extension relative to the axes. Any or all of thisinformation can be used to navigate and position the rod 36 relative tothe femur. At a point in time during or after placement of the rod 36,its tracking may be “handed off” from the impactor fiducial 14 to thefemur fiducal 14 as discussed below.

Once the extramedullary rod 36, intramedullary rod, other type of rod orany other type of structural member has been placed, instrumentation canbe positioned as tracked in position and orientation by sensor 16 anddisplayed on screen face 24. Thus, a cutting block 34 of the sort usedto establish the condylar anterior cut, with its fiducial 14 attached,is introduced into the field and positioned on the rod 36. Because thecutting block 34 corresponds to a particular implant product and can beadjusted and designated on screen to correspond to a particular implantsize of that product, the computer 18 can generate and display a graphicof the cutting block 34 and the femoral component overlain on thefluoroscopic image as shown in FIGS. 34-37. The surgeon can thusnavigate and position the cutting block 34 on screen using not onlyimages of the cutting block 34 on the bone, but also images of thecorresponding femoral component which will be ultimately installed. Thesurgeon can thus adjust the positioning of the physical cutting block 34component, and secure it to the rod 36 in order to resect the anteriorof the condylar portion of the femur in order to optimally fit andposition the ultimate femoral component being shown on the screen. FIG.35 is another view of the cutting block 34 of FIG. 32 being positioned.

Cutting blocks 34 and other instrumentation may be positioned relativeto femoral, tibial or other bone using instruments and devices such asvariable alignment or orientation modules, versions of which accordingto particular aspects of the invention are shown in FIGS. 38-47. FIGS.38-41 show a first version of a variable alignment module 54. Itincludes a post 58 which may be connected to an extramedullary rod 36 asshown in FIG. 28, an intramedullary rod or as otherwise desired. Post 58connects to a cutting block or other instrument 34 via two gimbalmembers, first or outer gimbal 60 and a second or inner gimbal 62. Firstor outer gimbal 60, which may be mechanically connected to cutting block34 as shown in FIGS. 40 A-C and 41, is connected in pivoting fashion tosecond gimbal 62 using, for example, openings 64 and pins 70. Firstgimbal 60 receives a worm gear 66 which cooperates with a first follower(located on the second gimbal 62) whose teeth follow action of the wormgear 66 in order to vary the angle of the first and second gimbals 60,62 relative to each other. In the embodiment shown in FIGS. 38-41, wormgear 66 in this fashion adjusts varus/valgus angulation of cutting blockor instrument 34 relative to bone.

FIGS. 39A-C shows more clearly the post 58 (which can receive and besecured to extramedullary rod 36 or other devices using, for example, abore and pin 70) and second gimbal 62 connected in pivoting relationshipin a fashion conceptually similar to the manner in which first andsecond gimbals 60 and 62 are connected. As shown in FIG. 39C, post 58penetrates gimbal 62 in pivoting fashion using openings 64 and pins 70.Second gimbal 62 receives a worm gear 68 which cooperates with a secondfollower on post 58 to vary the angle of post 58 relative to secondgimbal 62.

As shown in FIGS. 40A-C and 41, the angulation of cutting block 34relative to rod 36 may be varied in varus and valgus using worm gear 66and flexion/extension using worm gear 68.

FIGS. 42-45 show a variable alignment module which may used forinstrumentation employed in connection with the tibia. The operation andstructure are conceptually similar to the femoral module shown in FIGS.38-41. Here, a first gimbal 76 may be rigidly or otherwise mounted to amember 74 which in turn receives instrumentation such as a cutting block75. First gimbal 76 connects to second gimbal 78 using pin 82 extendingthrough holes 80 in first gimbal 76 to capture second gimbal 78 so thatit may pivot relative to first gimbal 76. A worm gear 84 connects tofirst gimbal 76 and drives a follower on second gimbal 78 to adjustangulation of second gimbal 78 relative to first gimbal 76. Worm gear 84can thus adjust flexion/extension orientation of the cutting block 75relative to the tibia.

A post 86 which receives extramedullary rod 36 or other rod orbone-connecting structure, and which may be formed of a cylindricalmember in combination with other structure for retaining rod 36 indesired relationship, is received relative to second gimbal 78 inadjustable fashion. In the embodiment shown in FIGS. 42-45, anadjustment screw 88 cooperates with a slot in the second gimbal 78 inorder to allow the post 86 to rotate within gimbal 78 and be secured atdesired angulation. Adjustment screw 88 and slot 90 are but onevariation of any adjustment mechanism, such as worm and follower, rackand pinion, vernier, or other angulation control devices or structureswhich could be used in this embodiment, the embodiment shown in FIGS.38-41 other embodiments. Accordingly, this structure may be used toadjust varus/valgus alignment of cutting block 75.

With respect to the femoral structure shown in FIGS. 38-41 and thetibial structure shown in FIGS. 42-45, other structures which allowadjustment of angulation or orientation not only of the two axis, butany desired angulation of cutting block 75 relative to rod 36 (and thusbone) can be used. Gimbals can be reversed in structure and function,different calibration and adjustment mechanisms can be used includingwith indicia in order to introduce repeatability, and other structuresmay be employed as well. Fiducials 14 can be attached to any desiredportion of these structures, directly or indirectly, for tracking inaccordance with aspects of the invention.

FIGS. 46 and 47 show two structures among many which can be used toadjust positioning of cutting block 34 or other instrumentation relativeto rod 36. In the version shown in FIG. 46, rod 36 which may beextramedullary, intramedullary, or otherwise, features a spherical orotherwise curved three-dimensional head with a generally concentricthreaded bore. An adjustment bolt 90 features threads which cooperatewith the threads in head 36. The bolt 90 penetrates cutting block 34 indesired fashion so that the cutting block 34, which features a recess 92on its bottom surface that corresponds to the shape of the head of 36,however closely, can be angulated as desired in any dimension and thenset via tightening of bolt 90 at any desired angulation in multipleplanes.

FIG. 47 shows a variation in which the cutting block 34 may be connectedto external fixation systems 92, such as those described U.S. Pat. No.5,728,095, which is incorporated herein by this reference, in order toadjustably position the cutting block 34 relative to femoral or tibialbone. As described in that patent and others on the subject,calibrations may be employed on the struts connecting the cutting block34 and the fixator element 92 in order for repeatability andcontrollability of angulation of cutting block 34 relative to fixationelement or device 92.

FIGS. 48-52 show instrumentation that has been navigated and positionedon the proximal portion of the tibia 10 as shown in FIG. 52 and astracked by sensor 16 and on screen by images of the cutting block andthe implant component as shown in FIGS. 48-51.

FIGS. 53 and 54 show other onscreen images generated during this bonemodification process for purposes of navigation and positioning cuttingblocks 34 and other instrumentation for proper resection and othermodification of femur and tibia in order to prepare for trial componentsand implant components according to instrumentation, systems, andprocesses of the embodiment of the present invention shown in FIGS.4-75.

FIGS. 55-59 also show instrumentation being positioned relative to femur12 as tracked by the system for resection of the condylar component inorder to receive a particular size of implant component. Various cuttingblocks 34 and their attached fiducials can be seen in these views.

FIG. 60 shows a femoral component overlaid on the femur asinstrumentation is being tracked and positioned in order for resectionof bone properly and accurately to be accomplished. FIG. 61 is anothernavigational screen face showing a femoral component overlay asinstrumentation is being positioned for resection of bone.

FIG. 62 is tibial component overlay information on a navigation screenas the cutting block 34 for the tibial plateau is being positioned forbone resection.

FIGS. 63 and 64 show femoral component and tibial component overlays,respectively, according to certain position and orientation of cuttingblocks/instrumentation as resecting is being done. The surgeon can thusvisualize where the implant components will be and can assess fit, andother things if desired, before resections are made.

Navigation, Placement and Assessment of Trials and Implants

Once resection and modification of bone has been accomplished, implanttrials can then be installed and tracked by the system in a mannersimilar to navigating and positioning the instrumentation, as displayedon the screen 24. Thus, a femoral component trial, a tibial plateautrial, and a bearing plate trial may be placed as navigated on screenusing computer generated overlays corresponding to the trials.

During the trial installation process, and also during the implantcomponent installation process, instrument positioning process or at anyother desired point in surgical or other operations according to thepresent invention, the system can transition or segue from tracking acomponent according to a first fiducial to tracking the componentaccording to a second fiducial. Thus, as shown as FIG. 36, the trialfemoral component is mounted on an impactor to which is attached afiducial 14. The trial component is installed and positioned using theimpactor. The computer 18 “knows” the position and orientation of thetrial relative to the fiducial on the impactor (such as by priorregistration of the component attached to the impactor) so that it cangenerate and display the image of the femoral component trial on screen24 overlaid on the fluoroscopic image of the condylar component. At anydesired point in time, before, during or after the trial component isproperly placed on the condylar component of the femur to align withmechanical axis and according to proper orientation relative to otheraxes, the system can be instructed by foot pedal or otherwise to begintracking the position of the trial component using the fiducial attachedto the femur rather than the one attached to the impactor. According tothe preferred embodiment, the sensor 16 “sees” at this point in timeboth the fiducials on the impactor and the femur 12 so that it already“knows” the position and orientation of the trial component relative tothe fiducial on the impactor and is thus able to calculate and store forlater use the position and orientation of the trial component relativeto the femur 12 fiducial. Once this “handoff” happens, the impactor canbe removed and the trial component tracked with the femur fiducial 14 aspart of or moving in concert with the femur 12. Similar handoffprocedures may be used in any other instance as desired in accordancewith the present invention.

FIG. 66 shows the tibial plateau trial being tracked and installed in amanner similar to femoral component trial as discussed above.Alternatively, the tibial trial can be placed on the proximal tibia andthen registered using the probe 26. Probe 26 is used to designatepreferably at least three features on the tibial trial of knowncoordinates, such as bone spike holes. As the probe is placed onto eachfeature, the system is prompted to save that coordinate position so thatthe system can match the tibial trial's feature's coordinates to thesaved coordinates. The system then tracks the tibial trial relative tothe tibial anatomical reference frame.

Once the trial components are installed, the surgeon can assessalignment and stability of the components and the joint. During suchassessment, in trial reduction, the computer can display on monitor 24the relative motion between the trial components to allow the surgeon tomake soft tissue releases and changes in order to improve the kinematicsof the knee. The system can also apply rules and/or intelligence to makesuggestions based on the information such as what soft tissue releasesto make if the surgeon desires. The system can also display how the softtissue releases are to be made.

FIG. 67 shows the surgeon articulating the knee as he monitors thescreen which is presenting images such as those shown in FIGS. 68-70which not only show movement of the trial components relative to eachother, but also orientation, flexion, and varus/valgus. During thisassessment, the surgeon may conduct certain assessment processes such asexternal/internal rotation or rotary laxity testing, varus/valgus tests,and anterior-posterior drawer at 0 and 90 degrees and mid range. Thus,in the AP drawer test, the surgeon can position the tibia at the firstlocation and press the foot pedal. He then positions the tibia at thesecond location and once again presses the foot pedal so that thecomputer has registered and stored two locations in order to calculateand display the drawer and whether it is acceptable for the patient andthe product involved. If not, the computer can apply rules in order togenerate and display suggestions for releasing ligaments or othertissue, or using other component sizes or types, such as shown, forexample, in FIGS. 71-74. Once the proper tissue releases have been made,if necessary, and alignment and stability are acceptable as notedquantitatively on screen about all axes, the trial components may beremoved and actual components navigated, installed, and assessed inperformance in a manner similar to that in which the trial componentswere navigated, installed, and assessed.

FIG. 75 is another computer generated 3-dimensional image of the trialcomponents as tracked by the system during trialing.

At the end of the case, all alignment information can be saved for thepatient file. This is of great assistance to the surgeon due to the factthat the outcome of implant positioning can be seen before anyresectioning has been done on the bone. The system is also capable oftracking the patella and resulting placement of cutting guides and thepatellar trial position. The system then tracks alignment of the patellawith the patellar femoral groove and will give feedback on issues, suchas, patellar tilt.

The tracking and image information provided by instrumentation, systems,and processes according to the present invention facilitate telemedicaltechniques, because they provide useful images for distribution todistant geographic locations where expert surgical or medicalspecialists may collaborate during surgery. Thus, instrumentation,systems, and processes according to the present invention can be used inconnection with computing functionality 18 which is networked orotherwise in communication with computing functionality in otherlocations, whether by PSTN, information exchange infrastructures such aspacket switched networks including the Internet, or as otherwise desire.Such remote imaging may occur on computers, wireless devices,videoconferencing devices or in any other mode or on any other platformwhich is now or may in the future be capable of rending images or partsof them produced in accordance with the present invention. Parallelcommunication links such as switched or unswitched telephone callconnections may also accompany or form part of such telemedicaltechniques. Distant databases such as online catalogs of implantsuppliers or prosthetics buyers or distributors may form part of or benetworked with functionality 18 to give the surgeon in real time accessto additional options for implants which could be procured and usedduring the surgical operation.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the invention, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present invention shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

1. A process for conducting knee surgery, comprising: a. exposing bonesin the vicinity of knee joint; b. fastening a rod to bone in thevicinity of the knee joint in a manner intended at least coarsely toalign the rod to a desired axis relative to the bone; c. attaching a rodretention component of an alignment module to the rod, the alignmentmodule comprising: i. a rod retention component adapted to connect tothe rod; ii. a surgical instrumentation retention component adapted toconnect to surgical instrumentation; iii. an intermediate componentadapted to connect to the rod retention component in a fashion thatallows the rod retention component and intermediate component to rotaterelative to each other about at least one axis, and adapted to connectto the surgical instrumentation retention component in a fashion thatallows the surgical instrumentation retention component and theintermediate component to rotate relative to each other about at leastone axis; iv. an adjustment mechanism connecting the intermediatecomponent and the rod retention component, the adjustment mechanismadapted to control and fix orientation of the intermediate componentrelative to the rod retention component; and v. an adjustment mechanismconnecting the intermediate component and the surgical instrumentationretention component, the adjustment mechanism adapted to control and fixorientation of the intermediate component and the surgicalinstrumentation retention component; d. attaching instrumentation to thealignment module; e. adjusting at least one of the adjustment mechanismsin order to finely align the instrumentation relative to the bone; f.resecting bone using the instrumentation; g. attaching a surgicalimplant to the resected bone; h. reassembling the knee; and i. closingthe exposed knee.
 2. The process according to claim 1, furthercomprising attaching a fiducial at least indirectly to theinstrumentation and tracking the instrumentation position using thefiducial and a surgical navigation system.
 3. The process according toclaim 1, in which fastening the rod to the bone does not includepenetrating the medullary canal with the rod.
 4. The process accordingto claim 1, in which the instrumentation is adjusted by adjusting bothadjustment mechanisms.
 5. A process for conducting knee surgery,comprising: a. exposing bones in the vicinity of knee joint; b.fastening a structural member to bone in the vicinity of the knee jointin a manner intended at least coarsely to align the structural member toa desired axis relative to the bone; c. attaching a second member of analignment module to the structural member, the alignment modulecomprising: i. a first member adapted to be connected toinstrumentation; ii. a second member connected to the first member in afashion that allows the second member and the first member to be variedin orientation relative to each other about at least two substantiallyorthogonal axes; iii. adjustment structure for controlling motion of thesecond member relative to the first member and for fixing the positionof the second member relative to the first member; iv. attachinginstrumentation to the first member; and v. attaching at least onefiducial to the instrumentation, at least indirectly; d. trackingorientation of the instrumentation relative to bone using the fiducialand a surgical navigation system; e. adjusting the adjustment structurein order to finely align the instrumentation relative to the bone; f.resecting bone using the instrumentation; g. attaching a surgicalimplant to the resected bone; h. reassembling the knee; and i. closingthe exposed knee.
 6. A process according to claim 5, in which trackingorientation of the instrumentation relative to the bone involvesstoring, processing and displaying radiograms of the bone taken beforethe process begins.